ABP 692 vs Ocrelizumab for Multiple Sclerosis

Recruiting at 108 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Must not be taking: Systemic corticosteroids, Immunosuppressants

Disqualifiers: Primary progressive MS, Secondary progressive MS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

444 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, ABP 692 and Ocrelizumab, for individuals with relapsing-remitting multiple sclerosis (RRMS). The researchers aim to determine if ABP 692, an experimental treatment, functions similarly to Ocrelizumab by comparing their effects on new brain lesions over 24 weeks. Participants will be divided into groups to receive either ABP 692 or Ocrelizumab from the US or EU. Suitable candidates have RRMS, have not experienced a recent relapse, and show signs of active disease. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to help bring a new treatment closer to availability.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications, but it mentions that certain medications might be prohibited. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ABP 692 is being compared to Ocrelizumab to evaluate its safety and effectiveness. Previous studies suggest that ABP 692 is designed to function like Ocrelizumab, which treats multiple sclerosis.

Ocrelizumab is generally well-tolerated, though some people experience side effects. The most common are reactions at the injection site, affecting about half of the patients. These reactions can include itchy skin, a rash, or fatigue. Some individuals might also experience coughing or a sore throat.

As a Phase 3 trial, ABP 692 has already passed initial safety tests. This phase assesses safety on a larger scale, providing some evidence that ABP 692 might be as safe as Ocrelizumab, though more data is needed for confirmation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ABP 692 because it offers a potentially new option for treating relapsing-remitting multiple sclerosis (RRMS). Unlike many existing therapies that target B-cells, ABP 692 is designed to be a biosimilar to Ocrelizumab, which is already a standard treatment but with a slightly different formulation. This could mean similar effectiveness with potentially different side effects or cost benefits. Additionally, the inclusion of both ABP 692 and Ocrelizumab in treatment plans allows for direct comparison, which could provide valuable insights into optimizing RRMS treatment.

What evidence suggests that this trial's treatments could be effective for multiple sclerosis?

This trial will compare ABP 692 with Ocrelizumab for treating relapsing-remitting multiple sclerosis (RRMS). Studies have shown that Ocrelizumab effectively reduces relapses and disease activity in people with RRMS and helps slow the progression of disability. In two large studies, Ocrelizumab outperformed another approved treatment for managing relapsing MS. ABP 692, which participants in this trial may receive, is being tested to determine if it matches Ocrelizumab's effectiveness. The trial examines how both drugs can reduce new active brain lesions, which indicate MS activity. While researchers continue to study ABP 692, it aims to offer similar benefits as Ocrelizumab in treating RRMS. ^{1 3 4 6 7}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for individuals with Relapsing-Remitting Multiple Sclerosis (RRMS) as per McDonald Criteria. Participants should have a disability score that indicates they're still mobile and have had recent MS activity. They must be stable, without relapses in the last 28 days.

Inclusion Criteria

My disability level allows me to walk without aid or rest for at least 200 meters.

I have been diagnosed with RRMS according to the 2017 McDonald Criteria.

Evidence of recent MS activity as defined by the study protocol

Exclusion Criteria

I do not have any significant medical conditions.

My condition is diagnosed as primary or secondary progressive MS.

I have no known allergies or reactions to the study's procedures or medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive initial doses of 300 mg IV infusion on Day 1 and Day 15, followed by a 600 mg IV infusion at Week 24

24 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

72 weeks

Periodic visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ABP 692
• Ocrelizumab

Trial Overview

The study aims to compare ABP 692 with Ocrelizumab from the US and EU by looking at how similar their effects are on the body (PK) and their impact on brain lesions related to MS over six months, using MRI scans.

How Is the Trial Designed?

Group I: Ocrelizumab (US)/ABP 692 Experimental Treatment 2 Interventions

Participants affected by RRMS will receive an initial dose of 300 mg Ocrelizumab (US) IV infusion on Day 1, followed by a second dose of 300 mg Ocrelizumab (US) IV infusion on Day 15. At Week 24, the treatment will switch to a 600 mg Ocrelizumab (US) IV infusion of ABP 692.

Group II: Ocrelizumab (EU) Experimental Treatment 1 Intervention

Participants affected by RRMS will receive an initial dose of 300 mg Ocrelizumab (EU) IV infusion on Day 1, followed by a 300 mg Ocrelizumab (EU) IV infusion on Day 15. At Week 24, participants will receive a dose of 600 mg Ocrelizumab (EU) IV infusion.

Group III: ABP 692 Experimental Treatment 1 Intervention

Participants affected by relapsing-remitting multiple sclerosis (RRMS) will receive an initial dose of 300 mg ABP 692 intravenous (IV) infusion on Day 1, followed by a second dose of 300 mg ABP 692 IV infusion on Day 15. A subsequent dose of 600 mg ABP 692 IV infusion will be administered 24 weeks after the initial dose.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Published Research Related to This Trial

Ocrelizumab is a humanized anti-CD20 monoclonal antibody specifically designed to deplete B cells, which are implicated in the development of multiple sclerosis (MS).

Approved in March 2017 in the USA for treating both relapsing and primary progressive forms of MS, ocrelizumab represents a significant advancement in MS therapy, with its approval in the EU currently pending.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab: First Global Approval. Frampton, JE.[2022]

Ocrelizumab is an effective treatment for both relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), showing significant reductions in relapse rates and disease progression over at least 7.5 years of treatment.

The drug is generally well tolerated, with no new safety concerns identified during long-term use, and offers the convenience of infusions every six months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab: A Review in Multiple Sclerosis. Lamb, YN.[2023]

In a Phase IIIb study involving 141 patients, shorter-duration infusions of ocrelizumab (600 mg over 2 hours or 300 mg over 1.5 hours) were evaluated, resulting in a mean infusion time reduction of approximately 1.09 and 0.79 hours, respectively.

The rate of infusion-related reactions (IRRs) was mild-to-moderate, with no Grade 3-4 IRRs reported, indicating that shorter infusions do not compromise patient safety compared to standard infusion durations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety results of administering ocrelizumab per a shorter infusion protocol in patients with primary progressive and relapsing multiple sclerosis. Vollmer, TL., Cohen, JA., Alvarez, E., et al.[2022]

In a study of 130 individuals with relapsing and progressive multiple sclerosis, treatment with ocrelizumab led to significant improvements in health-related quality of life (HRQOL) after 12 months, particularly in mental health domains.

The improvements were measured using patient-reported outcome tools, showing enhanced scores in areas like vitality, emotional health, and reduced anxiety, indicating that ocrelizumab not only affects physical symptoms but also positively impacts mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of ocrelizumab on health-related quality of life in individuals with multiple sclerosis. Glanz, BI., Zurawski, J., Casady, EC., et al.[2022]

Ocrelizumab is an effective B-cell-targeted therapy for multiple sclerosis (MS), showing significant reductions in relapse rates and disability progression in both relapsing and primary progressive MS, based on data from multiple phase III trials involving human subjects.

Approved in March 2017, ocrelizumab is the first treatment specifically for primary progressive MS, with a recommended dosing of 600 mg intravenously every 6 months, though it may cause infusion-related reactions and infections as side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab: A New B-cell Therapy for Relapsing Remitting and Primary Progressive Multiple Sclerosis. Stahnke, AM., Holt, KM.[2022]

In a study of 87 multiple sclerosis (MS) patients, those treated with ocrelizumab (OCR) showed a lower seroconversion rate (39.3%) after vaccination compared to 100% in MS patients not on disease-modifying therapies, indicating that OCR treatment may impair vaccine response.

The timing of vaccination relative to OCR infusion and the patient's B-cell count significantly influenced the humoral response, with better outcomes observed in patients vaccinated later and those with detectable B-cells, suggesting that vaccination timing should be carefully considered for OCR-treated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal humoral response after SARS-CoV-2 vaccination in ocrelizumab treated MS patients: To wait and repopulate? van Kempen, ZLE., Wieske, L., Stalman, EW., et al.[2022]

Ocrelizumab is the first drug approved by the European Medicines Agency for treating both early primary progressive multiple sclerosis and relapsing forms of multiple sclerosis, highlighting its significance in MS treatment.

The review discusses the safety and effectiveness of ocrelizumab, indicating it has undergone rigorous evaluation to support its use in adults with multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab for multiple sclerosis. [2018]

In a post hoc analysis of pivotal trials, ocrelizumab significantly reduced the risk of confirmed disability progression in multiple sclerosis patients with higher baseline disability (Expanded Disability Status Scale scores ≥4.0).

The analysis included patients from the OPERA trials (relapsing MS) and ORATORIO trial (primary progressive MS), showing that ocrelizumab was more effective than interferon β-1a and placebo in slowing disability progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploratory analysis of the efficacy of ocrelizumab in patients with multiple sclerosis with increased disability. Wolinsky, JS., Engmann, NJ., Pei, J., et al.[2022]

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Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

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ABP 692 vs Ocrelizumab for Multiple Sclerosis

Ocrelizumab has been shown to reduce relapse rates and disease activity in patients with relapsing multiple sclerosis and slow disease progression in primary ...

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nationalmssociety.org

nationalmssociety.org/how-you-can-help/get-involved/participate-in-research-studies/participate-in-clinical-trials/ct-ocrelizumab-biosimilar

Clinical Trial: ABP 692 in RRMS

Participate in the clinical trial testing if experimental drug ABP 692 is as effective as Ocrevus® for relapsing-remitting MS. Learn more about this study.

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This clinical trial tests the efficacy and safety of ABP 692 compared to Ocrelizumab in treating patients with Relapsing-Remitting Multiple ...

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Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

The main objectives of the study are to demonstrate pharmacokinetics (PK) similarity between ABP 692 and Ocrelizumab (US), and ABP 692 and Ocrelizumab (EU), ...

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ABP-692 - Drug Targets, Indications, Patents

A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Pharmacodynamics, Clinical Effects, and Safety between ABP 692 and Ocrevus® ...